Keywords : Drug, medicine, CNS drug, pharmaceutical excipient, remedy, morphine, Cardiac glycoside, methylcellulose
INTRODUCTION STUDY BACKGROUND Because the use of plant-derived drugs has become so widespread, there is a great need to develop an up-to-date base of market information about these products. More than four years have passed since BCC Research published its first version of Botanical and Plant-Derived Drugs: Global Markets. This report is an update of that one. Both analyze the key growth areas in plant-derived drugs...
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INTRODUCTION
STUDY BACKGROUND
Because the use of plant-derived drugs has become so widespread, there is a great need to develop an up-to-date base of market information about these products. More than four years have passed since BCC Research published its first version of Botanical and Plant-Derived Drugs: Global Markets. This report is an update of that one. Both analyze the key growth areas in plant-derived drugs, develop quantitative market projections and discuss compliance with the requirements for the botanical category of drugs, created in 2004, with its own U.S. FDA regulations, guidelines and review process.
STUDY GOAL AND OBJECTIVES
The present study meets this need by focusing on the global market for plant-derived drugs in light of the most recent available information. In addition to looking at future and current markets for a wide variety of new, reformulated and established products, the study will analyze technological, environmental, legal/regulatory and socioeconomic developments that may influence the market for plant-derived drugs.
This report provides an analysis of the emerging botanical drug industry and markets, geographically and by therapeutic area. The future of plant-derived drugs as a whole is discussed.
More specific objectives are as follows:
Identify and classify the botanical and plant-derived drugs that have been commercialized to date.
Identify and evaluate the impact of factors that will drive future demand for botanical drugs with a focus too on plant-based drugs overall.
Forecast the volume and value of shipments of botanical drugs through 2017.
Describe botanical drugs that are currently in clinical testing or the approval stage and assess the probability that they will be commercialized successfully in the next five years.
Forecast the potential market for these drug candidates, weighted to reflect the estimated probability that they will be commercialized.
Identify the leading manufacturers of plant-derived drugs and the firms that may become important players in the next five years.
Assess the long-term outlook for the plant-derived drug industry, taking into account market opportunities as well as technological, environmental, legal/regulatory and socioeconomic factors.
INTENDED AUDIENCE
The report has been written for the entire pharmaceutical community, but is tailored especially for readers with an interest in the marketing, management and public policy dimensions of botanical drugs, including readers in the following:
The pharmaceutical industry, especially companies supplying bulk or formulated plant-derived drugs or companies that are planning to enter this field.
Medical research institutions.
International organizations and governmental organizations with relevant responsibilities such as health, drug safety, conservation and the environment, and foreign trade.
Investors.
The financial and analyst community.
SCOPE OF REPORT
This report is an analytical business tool whose primary purpose is to describe the botanical drug industry with the overall plant-derived drug industry as a backdrop and the global market for these drugs going forward.
For the purposes of this report, botanicals are those drugs that are FDA-approved under the botanical drug pathway, while plant-derived drugs are both botanicals as well as other approved drugs that contain a mixture of natural plant-derived and synthetic or semisynthetic substances.
The study’s main focus is on legal, prescription-required therapeutic medicines sold in the open market. The study does not specifically cover herbals generally sold as dietary supplements (i.e., to promote overall “wellness” rather than to address a specific medical condition or symptoms). While there is a substantial market for these products, the medical value of many of these substances has not been demonstrated conclusively.
The study also does not cover the following:
Underground or illicit drugs.
Home remedies.
Tribal medicines.
Drugs derived from Archaea, bacteria and fungi (molds and yeasts).
Non-medicinal plant substances such as laxative cellulose and pectin fiber.
Intravenously delivered nutrients of plant origin, such as dextrose.
Plant-derived substances serving as pharmaceutical excipients, such as starch, methylcellulose, guar gum, vegetable oils, fatty acids, cocoa butter and candelilla wax.
Plant substances serving in cosmetics, toiletries and personal care products.
Microbial fermentation products, even those made with culture media incorporating corn steep liquor, starch or other plant-derived nutrients.
Marine life.
The format of the study is organized around the following topics:
Major types and applications of botanical drugs with plant-derived drugs as their backdrop.
Industry structure.
Market size and segmentation, including the breakdown of sales by therapeutic area and geographic area.
Market drivers.
Market projections through 2017.
Competition.
Observations and conclusions regarding the future of the botanical and plant-derived drug industry.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methods were used in preparing this research report. The findings and conclusions contained in this report are based on information gathered from development companies and sales and manufacturers involved with primarily, botanical drugs as defined by the U.S. FDA and secondarily, the larger world of plant-derived drugs, which encompasses botanical drugs as a subsegment. Additional data were obtained from extensive reviews of secondary sources such as trade publications, trade associations, company literature and online databases.
COMMERCIAL DRUGS
In the case of commercial drugs, the study starts by projecting the demand for various types of medical applications, such as chemotherapy drugs, asthma and medicine, which use plant-derived drugs as part of the therapy. The implied demand for plant-derived drugs is then estimated based on historical relationships, adjusted to reflect such factors as the availability of alternative, non-plant-derived drugs; price relationships; and other buyer criteria as well as other information from relevant companies.
DEVELOPMENTAL DRUGS
The approach described above is useful mainly for drugs that are already in commercial use. A somewhat different approach is used to project demand for drugs that are still in the development or regulatory testing and approval processes, but are expected to be commercialized in the 2012 to 2017 time frame.
In some cases, a new plant-derived drug’s developers or other industry analysts are projecting that the drug will be commercialized by a particular year (e.g., 2017). Where this is not the case, BCC uses the timeline for the U.S. FDA approval process as a yardstick for evaluating the likelihood that a particular plant-based drug will be commercialized in the next five years. (Even in cases where developers are projecting a particular year, BCC has used the FDA approval process timeline as a kind of reality check.)
Since the market projections in this report include only products that are likely to be commercialized in the five-year period of 2012 to 2017, the projections are limited to plant-derived drug candidates that are likely to receive FDA approval by 2017. This in turn generally limits the field of drugs that are in Phase III clinical trials or in the final FDA approval process.
ANALYST CREDENTIALS
Kim Lawson is a graduate of Mount Holyoke College with a degree in English Literature. She acquired experience as a healthcare journalist, including working for John Wiley & Sons for years as a print reporter, before serving as a research analyst in a small market research firm that focused on pharmaceuticals and biotechnology in the Research Triangle Park area of North Carolina. Before joining that firm, Kim published two reports on emerging and established diagnostics and therapeutics for benign and cancerous breast disease. Ms. Lawson has authored several market research reports for BCC Research.
Global Drug And Medication Industry
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 1
STUDY BACKGROUND 1
STUDY GOAL AND OBJECTIVES 1
INTENDED AUDIENCE 1
SCOPE OF REPORT 2
METHODOLOGY AND INFORMATION SOURCES 3
COMMERCIAL DRUGS 3
DEVELOPMENTAL DRUGS 3
TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 3
ANALYST CREDENTIALS 4
RELATED BCC PUBLICATIONS 4
BCC ONLINE SERVICES 4
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,
THROUGH 2017 ($ BILLIONS) 8
SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,
2010-2017 ($BILLIONS) 8
CHAPTER 3 OVERVIEW 12
BRIEF HISTORY OF PLANT-DERIVED MEDICINES 12
TABLE 1 KEY DATES IN BOTANICAL MEDICINE 13
TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 14
OPPORTUNITY LIES BEYOND WHAT IS KNOWN 14
FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE
FDA, 2008 (% SHARES) 14
GETTING STARTED 16
KEY DRIVERS 17
KEY CHALLENGES 18
U.S. GOVERNMENT INVESTMENT 19
INDUSTRY INVESTMENT 20
TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 24
TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 25
BOTANICAL DRUGS DEFINED 27
UNDERSTANDING THE REGULATORY PROCESS 29
TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 30
INVESTIGATIONAL NEW DRUG APPLICATIONS 30
CLINICAL TRIALS 30
NEW DRUG APPLICATION 31
THE FIRST APPROVED BOTANICAL 31
ADVICE FROM FDA BASED ON VEREGEN APPROVAL 33
BOTANICAL CANDIDATES IN THE PIPELINE 33
CROFELEMER 33
FEMARELLE AND MENERBA 35
SHINBARO CAPSULE 36
DANSHEN DRIPPING PILL (CARDIOTONIC PILL) 37
EISO (EAST INDIAN SANDALWOOD OIL) 37
FAHF-2 39
TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101) 40
A GROWING PIPELINE 40
FIGURE 2 THERAPEUTIC AREAS OF FDA DRUG APPROVALS, 2011 (NO. OF DRUG
APPROVALS) 41
FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE, 2011 42
OVERALL PHARMA LANDSCAPE 42
TABLE 7 TOP PHARMA COMPANIES BY SALES, 2011 ($BILLIONS) 44
TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2012-2016 44
FIGURE 4 PHARMA DRUG SALES BY REGION, 2011 AND 2016 (% OF MARKET SHARE) 45
MAJOR CLASSES OF PLANT DRUGS 45
Terpenes and Steroids 46
Terpenes 46
Steroids 46
Alkaloids and Glycosides 47
Alkaloids 47
Ergot Alkaloids 47
Morphine Alkaloids 48
Vinca Alkaloids 48
Glycosides 48
Cardiac Glycosides 48
Anthraglycosides 48
Phenols 48
E. Cava Algae 49
Flavonoids 49
Resveratrol 49
Coumarin 49
Catechins 49
Proanthocyanidins 49
INTELLECTUAL PROPERTY 50
PRODUCTION 51
A NEW TYPE OF PRODUCTION: PLANT-MADE DRUGS 53
MOVING PRODUCTION FORWARD 53
ARTEMISININ: A CASE STUDY 55
SUPPLY AND LEGAL ISSUES 55
TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 56
DRUG DEVELOPMENT AND MANUFACTURE 57
TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 58
CHAPTER 4 MARKET SEGMENTATION 61
GEOGRAPHIC SEGMENTATION 61
SALES OF PLANT-DERIVED DRUGS BY REGION 61
THERAPEUTIC AREA SEGMENTATION 61
NUMBER OF PLANT-DERIVED DRUGS BY THERAPEUTIC AREA 61
TABLE 11 FDA APPROVED BOTANICAL DRUGS FORECAST, THROUGH 2017 (NO.) 61
FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY
THERAPEUTIC AREA, 2012 AND 2017 (% OF TOTAL BOTANICALS) 62
Value of Plant-Derived Drugs by Therapeutic Area 63
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, THROUGH 2017 ($BILLIONS) 63
FIGURE 6 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, 2012 AND 2017 (% OF MARKET SHARE BY DOLLAR VALUE) 64
CHAPTER 5 THERAPEUTIC AREAS FOR PLANT-DERIVED AND BOTANICAL DRUGS 66
HORMONE THERAPY AND METABOLISM APPLICATIONS 66
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE
DEVELOPMENT 67
INFECTIOUS DISEASE APPLICATIONS 67
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE DEVELOPMENT 68
PAIN AND CENTRAL NERVOUS SYSTEM DISEASE APPLICATIONS 72
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 73
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 74
CARDIOVASCULAR AND METABOLIC DISEASE 75
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE
DEVELOPMENT 76
RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND RELATED TO ORTHOPEDIC)
AND AUTOIMMUNE 77
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND
RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT 78
DERMATOLOGY APPLICATIONS 79
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE
DEVELOPMENT 80
GASTROINTESTINAL APPLICATIONS 81
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE* DEVELOPMENT 81
ONCOLOGY APPLICATIONS 82
TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2012 83
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 85
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE
FDA-APPROVED COMMERCIALIZATION, THROUGH 2017* 89
CHAPTER 6 COMPANY PROFILES 94
ABBOTT LABORATORIES 94
SOLVAY PHARMACEUTICALS 94
ADVANCED LIFE SCIENCES 95
AMAREX CLINICAL RESEARCH 95
AMERICAN ORIENTAL BIOENGINEERING 95
ANALYTICON DISCOVERY GMBH 96
ARTECEF BV 97
AVESTHAGEN INC. 97
BAYER HEALTHCARE PHARMACEUTICALS 98
BEIJING PEKING UNIVERSITY WBL BIOTECH CO. LTD. 99
BIONORICA SE 99
BIONUMERIK PHARMACEUTICALS INC. 99
BIONOVO INC. 100
BOEHRINGER INGELHEIM 101
PHARMATON SA 102
BOTANICAL DRUG CORP. 102
BRISTOL MYERS SQUIBB 103
CARDAX PHARMACEUTICALS 103
CHI-MED 104
CHINA BOTANIC PHARMACEUTICAL 104
CHONG KUN DANG PHARMACEUTICAL CORP. 105
CUBIST PHARMACEUTICALS INC. 106
CURAPHARM INC. 106
EISAI INC. 107
EKOMED LLC 107
ELI LILLY 108
FYTOKEM PRODUCTS INC. 108
GALAPAGOS NV 109
GENSPERA INC. 110
GLAXOSMITHKLINE 110
GREEN CROSS CORP. 112
GW PHARMACEUTICALS PLC 112
HANMI PHARM CO. LTD. 113
HETEROGENEITY LLC 114
INDENA 114
INDUS BIOTECH 116
JOHNSON & JOHNSON 116
LANZHOU FOCI PHARMACEUTICALS CO. LTD. 117
LIFEPHARMS INC. 117
LEO PHARMA 118
LUPIN LTD. 118
LUPIN PHARMACEUTICALS INC. 119
ROTTAPHARM|MADAUS 119
MADAUS GMBH 119
MEDICUS RESEARCH 120
MERLION PHARMACEUTICALS 120
MEDIGENE 121
MEDIGENE INC. 121
MERCK & CO. INC. 122
MICROBIO CO. LTD. 122
MYREXIS, INC 123
NAPO PHARMACEUTICALS INC. 123
NEUROGESX INC. 124
NOVARTIS INTERNATIONAL AG 124
PFIZER 125
PHARMANUTRIENTS BOTANICAL CORP. 127
PHYNOVA 127
TABLE 24 PHYNOVA PIPELINE 127
PHYTOCEUTICA INC. 128
PHYTOMYCO RESEARCH PVT. LTD. 129
PHYTOPHARM PLC 129
PHYTOPHARMACON INC. 130
PHYTRIX 130
PIRAMAL LIFE SCIENCES 131
PUNISYN PHARMACEUTICALS LTD. (RIMONEST LTD.) 131
PURGENESIS 132
RANBAXY LABORATORIES LTD. 132
SALIX PHARMACEUTICALS, INC 132
SANOFI 134
SCHWABE PHARMACEUTICALS 135
SE-CURE PHARMACEUTICALS LTD. 135
SEQUOIA SCIENCES INC. 136
SIRTRIS 136
SUNTEN PHYTOTECH CO. LTD. 137
TABLE 25 SUNTECH PHYTOTECH PIPELINE 137
TASLY PHARMACEUTICALS INC. 138
TCM BIOTECH INTERNATIONAL CORP. 138
VEDIC LIFESCIENCES PVT. LTD. 139
VIROXIS 140
VR LABORATORIES LLC 140
ZHEJIANG KANGLAITE GROUP CO LTD. 141
CHAPTER 7 APPENDIX 143
TABLE 26 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 143
TABLE 27 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 148
LIST OF TABLES
TABLE A FDA APPROVAL PROCESS FOR NEW DRUGS 3
SUMMARY TABLE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,
THROUGH 2017 ($ BILLIONS) 8
TABLE 1 KEY DATES IN BOTANICAL MEDICINE 13
TABLE 2 WELL KNOWN PLANT-DERIVED DRUGS 14
TABLE 3 SWOT ANALYSIS OF BOTANICAL DRUG DEVELOPMENT 24
TABLE 4 KEY INVESTMENTS IN BOTANICAL AND OTHER PLANT-DERIVED DRUGS 25
TABLE 5 DISTINCTIONS AMONG PRODUCTS THAT USE PLANTS MEDICINALLY 30
TABLE 6 BOTANICAL COMPOSITION OF MENERBA (MF 101) 40
TABLE 7 TOP PHARMA COMPANIES BY SALES, 2011 ($BILLIONS) 44
TABLE 8 MAJOR UPCOMING U.S. PATENT EXPIRIES, 2012-2016 44
TABLE 9 MAJOR PRODUCERS OF RAW MATERIALS FOR PLANT-BASED MEDICINALS 56
TABLE 10 KEY COMPANIES WITH NATURAL PRODUCT LIBRARIES 58
TABLE 11 FDA APPROVED BOTANICAL DRUGS FORECAST, THROUGH 2017 (NO.) 61
TABLE 12 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, THROUGH 2017 ($BILLIONS) 63
TABLE 13 PLANT-DERIVED HORMONE THERAPY AND METABOLISM DRUGS IN LATE STAGE
DEVELOPMENT 67
TABLE 14 PLANT-DERIVED INFECTIOUS DISEASE DRUGS IN LATE STAGE DEVELOPMENT 68
TABLE 15 BRAIN DISORDERS THAT ARE REFRACTORY TO SMALL MOLECULE DRUGS 73
TABLE 16 PLANT-DERIVED PAIN AND CNS DRUGS IN LATE STAGE DEVELOPMENT 74
TABLE 17 PLANT-DERIVED CARDIOVASCULAR AND METABOLIC DRUGS IN LATE STAGE
DEVELOPMENT 76
TABLE 18 PLANT-DERIVED RESPIRATORY, INFLAMMATION (BOTH NON-RELATED AND
RELATED TO ORTHOPEDIC) AND AUTOIMMUNE DRUGS IN LATE STAGE DEVELOPMENT 78
TABLE 19 PLANT-DERIVED DERMATOLOGY/WOUND CARE DRUGS IN LATE STAGE
DEVELOPMENT 80
TABLE 20 PLANT-DERIVED GASTROINTESTINAL DRUGS IN LATE STAGE* DEVELOPMENT 81
TABLE 21 ESTIMATED U.S. CANCER CASES BY GENDER, 2012 83
TABLE 22 PLANT-DERIVED ONCOLOGY DRUGS IN LATE STAGE DEVELOPMENT 85
TABLE 23 BOTANICAL DRUGS IN LATE STAGE DEVELOPMENT WITH POSSIBLE
FDA-APPROVED COMMERCIALIZATION, THROUGH 2017* 89
TABLE 24 PHYNOVA PIPELINE 127
TABLE 25 SUNTECH PHYTOTECH PIPELINE 137
TABLE 26 PLANT-DERIVED DRUGS: THEIR ORIGIN AND ACTIONS 143
TABLE 27 USEFUL RESOURCES FOR THE BOTANICAL DRUG INDUSTRY 148
LIST OF FIGURES
SUMMARY FIGURE GLOBAL FORECAST FOR BOTANICAL* AND PLANT-DERIVED DRUGS,
2010-2017 ($BILLIONS) 8
FIGURE 1 TYPE OF NATURAL PRODUCT DRUGS SUBMITTED AS IND APPLICATIONS TO THE
FDA, 2008 (% SHARES) 14
FIGURE 2 THERAPEUTIC AREAS OF FDA DRUG APPROVALS, 2011 (NO. OF DRUG APPROVALS) 41
FIGURE 3 SNAPSHOT OF U.S. FDA BOTANICAL PIPELINE, 2011 42
FIGURE 4 PHARMA DRUG SALES BY REGION, 2011 AND 2016 (% OF MARKET SHARE) 45
FIGURE 5 COMPOSITION OF FDA APPROVED BOTANICAL INDICATIONS FORECAST BY
THERAPEUTIC AREA, 2012 AND 2017 (% OF TOTAL BOTANICALS) 62
FIGURE 6 RELATIVE VALUES OF FDA APPROVED BOTANICAL DRUGS FORECAST BY
THERAPEUTIC AREA, 2012 AND 2017 (% OF MARKET SHARE BY DOLLAR VALUE) 64
